South Florida doctor offers innovative hearing device

Hearing-loss sufferers, this may be music to your ears: An innovative device with no external wires or batteries is offering patients a new chance at better hearing.

And South Florida has the only doctor in the state trained to surgically implant the Esteem, which the Food & Drug Administration called "the first totally implanted hearing system."

Cochlear implants have been around for years but are only for the profoundly deaf and work in a different way than the Esteem, said Dr. John Li, a board-certified ear, nose and throat specialist in Jupiter.

Cochlear implants mimic electrical signals that the brain can interpret as sound. The Esteem, by contrast, uses the ear's own infrastructure — the ear drum and middle ear bones — converting vibrations into electrical signals that are then amplified. The device, which is completely hidden inside the middle ear, is controlled by a remote the size of a garage door opener, with three programs, each with eight volume levels.

One Boynton Beach retiree who had the implant credits the gadget with giving him his life back.

"I'd say it's changed my life," said David Fink, 64, a former IT tech for Ford Motor Co. "It's given me the opportunity to participate in events I otherwise would have withdrawn from."

The device isn't for everyone. It comes at a hefty $40,000 price tag, which isn't covered by insurance, and it's most effective for those who have suffered genetic hearing loss or damage to the inner ear, according to the FDA.

Right now, Li is the only surgeon in Florida performing the surgical procedure to implant the device, according to Barbara Cederberg, president of Envoy Medical, maker of the Esteem.

Implanting the Esteem requires cutting off the ear's natural hearing process and replacing it with the device, rendering the patient deaf in that ear for six to eight weeks until the ear can heal and the device can be turned on.

The best part, Li said, is that the entire device is fully implanted, with no external wires or batteries, and the internal batteries are said to last five to nine years.

The 30- to 60-minute procedure to replace the batteries and upgrade the processing system costs $7,000 to $10,000, Cederberg said.

"The cool thing is there is nothing in the ear canal, so no one sees it. There's no occlusion and no feedback," said Li, who has implanted the Esteem on 40 patients over the past two years. All of them, he said, had "demonstrable improvement" in the vibrations they received, and 90 percent of them were satisfied with the results.

A multi-center clinical study on the Esteem found that 93 percent of recipients scored the same as or better than with their pre-implant hearing aids on a speech intelligibility test, according to a statement the FDA released when it approved the device in March 2010. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better.

Li said the implant comes with the same risks of any ear surgery — infection, bleeding, vomiting and hearing loss — but he said none of his patients have experienced severe side effects.

In the study quoted by the FDA, 7 percent of patients experienced facial paralysis, and 42 percent experienced "taste disturbance" as a result of the surgery, though the majority of those problems reportedly went away during the one-year study period.

Fink said he had no such issues, adding that the difference in his hearing was immediate and "profound." Before the implant, he had to upgrade his hearing aids five times over 14 years, and he stopped going to most movies, preferring foreign films with English subtitles because he had gotten so used to watching TV with closed captions.

"Now I can go to the movies," said Fink, who suffered his first bout of hearing loss after a 1964 Beatles concert. He also feels comfortable enough in the boardroom that he has joined the board of directors of his country club community.